Global Import Regulations for

Global Import Regulations for
Pre-Owned (Used and Refurbished) Medical Devices

Prepared by

Steven R. Harper
International Trade Specialist

Office of Microelectronics, Medical Equipment and Instrumentation International Trade Administration/Trade Development U.S. Department of Commerce

Revised September 2003

Table of Contents

Preface iv

Executive Summary vi

Market Listings 1

Argentina 1

Australia 19

Austria 20

Bahamas 21

Bangladesh 21

Barbados 21

Belgium 22

Belize 23

Bolivia 23

Brazil 26

Botswana 28

Cameroon 28

Canada 29

Chad 31

Chile 31

China 32

Colombia 34

Costa Rica 34

Croatia 35

Czech Republic 35

Denmark 36

Dominican Republic 37

Ecuador 37

Egypt 38

El Salvador 38

Ethiopia 42

European Union 42

Finland 43

France 44

Gabon 44

Germany 44

Ghana 48

Greece 49

Guatemala 49

Guinea 50

Haiti 51

Honduras 53

Hong Kong 54

Hungary 54

Iceland 55

India 56

Indonesia 58

Israel 59

Italy 60

Jamaica 61

Japan 61

Jordan 62

Kazakhstan 63

Kenya 63

Korea, South 64

Kuwait 68

Kyrgyzstan 69

Liberia 69

Luxembourg 71

Malawi 71

Malaysia 71

Mexico 72

Moldova 83

Morocco 84

Mozambique 86

Nepal 87

Netherlands 88

New Zealand 88

Nicaragua 89

Nigeria 89

Norway 91

Oman 92

Pakistan 92

Panama 95

Paraguay 98

Peru 98

Philippines 99

Poland 101

Portugal 105

Romania 105

Russia 106

Saudi Arabia 111

Serbia and Montenegro 111

Senegal 111

Singapore 113

Slovenia 114

South Africa 114

Spain 119

Sri Lanka 120

Sweden 121

Switzerland 121

Syria 122

Taiwan 123

Tanzania 123

Thailand 125

Trinidad & Tobago 125

Tunisia 126

Turkey 126

Turkmenistan 127

Uganda 128

Ukraine 129

United Arab Emirates 131

United Kingdom 132

Uruguay 134

Uzbekistan 134

Venezuela 137

Vietnam 138

Yemen 140

Zambia 141

Conclusions and Next Steps 142

Appendix A
Markets for Which No Information Was Available 145

Appendix B

Proposed Voluntary Self-Regulation of the
Pre-Owned Medical Device Industry 146

Preface

Purpose

This is the fifth edition of a report first issued in May 1999. This report seeks to collect and compile information on the regulations relating to the importation of pre-owned (used and refurbished) capital medical equipment in countries around the world. It also includes some information on market demand for such equipment.

Although this report is intended to serve as a general reference, it is not a definitive study and data is not available or is incomplete for many countries. This report is formally updated annually, but revisions to the country entries are made throughout the year if new material becomes available.

This report does not attempt to address the issue of re-use of single-use devices (SUDs). Such re-use remains a controversial practice and poses different safety issues than pre-owned capital equipment, which is designed for use with multiple patients over many years. Moreover, single-use devices are typically reprocessed by or for the original purchaser and thus generally do not enter into international trade.

Sources

The main sources for this report are responses filed by the staff of the U.S. Commercial Service (CS) stationed in U.S. embassies and consulates around the world to an annual request for information. This request, made by the Office of Microelectronics, Medical Equipment, and Instrumentation (OMMI), asks the Commercial Service trade specialists to review the existing entry and provide answers to several questions. In 2003, the questions were as follows:

1. 
   Are there special restrictions or tariffs that apply to used medical equipment that do not apply to new medical equipment?
   
2. 
   If a manufacturer or its agent has registered a medical device in the country, can a third party legally import the same device in used/refurbished condition without the used device being subjected to new safety inspections, etc.?
   
3. 
   Can public health institutions buy used or refurbished medical devices?
   
4. 
   Is there a market for used or refurbished medical devices?
   
5. 
   If there is a market, what types of used or refurbished medical equipment are in the greatest demand?
   

The second of these questions was asked for the first time in 2003 in order to clarify the ability of refurbishers—especially those not affiliated with the original equipment manufacturer (OEM)—to readily ship refurbished devices internationally.

The responses provided by the trade specialists vary from full-length reports—typically International Market Insight (IMI) or Industry Sector Analysis (ISA) reports—to short replies submitted by cable or e-mail. In many cases, the specialists simply confirm the existing entry. Entries submitted in report format are given the title and date of the report. Other entries are simply identified by whether they were submitted to OMMI by cable or e-mail and the date it was submitted. If the trade specialist confirms information submitted in previous years, both the original date of submission and the date of the confirmation are provided.

Thirty-four CS posts responded to the cable in 2003, somewhat fewer than in past years, perhaps reflecting the generally lack of change in import regulations for pre-owned medical devices. The 34 responding posts either prepared new IMI reports on pre-owned-medical equipment or sent a cable or e-mail to OMMI addressing the above questions.

The report also includes a small number of reports on the medical-device sector prepared by the CS trade specialists independently of OMMI’s request for information on the used-equipment sector, as well as some cables that many CS posts submitted in 1998 in response to a request from the Department of Commerce soliciting information on import regulation for used and refurbished equipment generally. Entries based on responses to this request carry a source indicating that they were submitted by the CS post via cable and bear a date in 1998.

Although an effort has been made to preserve the text of the original sources as much as possible, text has been reformatted and abridged in order to present a standardized and concise format. In some cases, the original sources have been summarized or edited.

Limitations of This Study

Because of the limitations of the sources, this report cannot be considered a definitive study of import regulations relating to pre-owned medical devices. Information, unfortunately, remains lacking for numerous countries.

In addition, many of the cables that were in response to the 1998 request for information about import regulations for used/refurbished equipment do not explicitly deal with medical equipment. The reporting officer, for example, may have looked only at general import regulations and thus not considered the possibility of more restrictive health regulations that affect the importation of used medical devices.

Finally, medical regulations are constantly changing. What may have been accurate when the market research was prepared may not be the case today. In addition, custom or health officials may interpret regulations that do not seem to present a problem in such a way as to result in market restrictions.

Updates of This Report

The most recent version of this report will be posted to ITA’s Medical Equipment home page, www.ita.doc.gov/td/mdequip.

Users of this report are encouraged to inform OMMI of any information found to be out of date or inaccurate. Contact:

Steven Harper
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]